ABSTRACT
This chapter places the "science" of biotechnology into today's regulatory structure, to define the constraints imposed on this waste management methodology by governments, and to explore the markets for biology-based waste treatment created by socio-political mandates. It begins with an overview of federal regulations that apply to bioremediation, and proceeds with a more detailed analysis of the key rules as they impact specific biodegradation methodologies. Since the majority of applications of biotechnology to hazardous waste require the organism or products derived from or made by the microorganism, the regulations addressed initially in the chapter are those which control the review process for individual microorganisms and bioproducts such as nonliving biomass or enzymes produced by the organisms. The chapter closes with the observation that the decision of which regulations apply to any single bioremediation site is ultimately that of the individual regulator who is in charge of a particular site.
